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MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
Sponsor: Zimmer Biomet
Summary
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.
Official title: Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
146
Start Date
2019-12-13
Completion Date
2028-07-29
Last Updated
2025-10-30
Healthy Volunteers
No
Interventions
Comprehensive Primary Micro Stem
Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.
Comprehensive Anatomic Versa-Dial Titanium Humeral Head
Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.
Locations (4)
Shoulder Clinic of Idaho
Boise, Idaho, United States
Beaumont Health
Royal Oak, Michigan, United States
University of Rochester
Rochester, New York, United States
Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont
Burlington, Vermont, United States